Composite stent graft

ABSTRACT

A composite stent graft has a balloon expandable stent portion ( 3 ), a tubular graft material portion ( 1 ) inside or outside of the balloon expandable stent portion and self expanding stents ( 5 ) associated with the tubular graft material portion. Part ( 7 ) of the balloon expandable stent portion can extend beyond the proximal end ( 9 ) of the tubular graft material portion. The tubular graft material can be polytetrafluoroethylene, dacron, polyamide, sub intestinal mucosa or any other suitable biocompatible material. A method of deploying which includes flaring a part ( 7 ) of the balloon expandable stent portion is also discussed.

RELATED APPLICATIONS

The present application is a divisional of application Ser. No.10/962,766, filed Oct. 12, 2004, which claims the benefit of the filingdate under 35 U.S.C. §119(e) of Provisional U.S. Patent Application Ser.No. 60/510,259, filed Oct. 10, 2003. All of the foregoing applicationsare hereby incorporated by reference.

BACKGROUND

1. Field of the Invention

This invention relates to a stent graft for use in the human or animalbody and more particularly to a stent graft which can be used as a sidebranch stent graft from a main vessel stent graft.

2. Background of the Invention

There is a problem with the deployment of a branch stent graft from amain stent graft into a side artery for instance. If a branch stentgraft is made substantially flexible, that is, for instance,manufactured with all self expanding stents, then there is a dangerthat, where a graft extends from a main graft through an aneurised spacewithin, for instance an aneurised aorta and then into a side branchartery, such as a renal artery, as the main graft moves the side branchcan kink which can close off the lumen through the branch stent graft.

If, however, an essentially rigid stent graft such as a balloonexpandable graft is used then the distal end of the stent graft cancause significant distortion of the side branch vessel and there can bea considerable problem with fibrosis, stenosis or damage to the sidebranch artery at the distal end of the stent graft.

Applicant has found that this problem can be solved by providing greaterflexibility of the branch stent graft within the side branch but havinga degree of rigidity in the main vessel region.

There is also a problem with holding the branch stent graft into afenestration in a main graft and this present invention proposes ways tosatisfy this requirement.

There can also be problems with stenosis at the distal end of the sidegraft and this invention proposes methods by which ingrowth at the endof a balloon expandable stent can be reduced.

BRIEF SUMMARY

In one form, therefore, the invention is said to reside in a compositestent graft having a tubular body with a lumen therethrough, the tubularbody comprising a balloon expandable stent portion, a tubular graftmaterial portion disposed inside or outside of the balloon expandablestent portion and extending from the balloon expandable stent portion atone end thereof and self expanding stents associated with the tubulargraft material portion disposed at least in the tubular graft materialportion extending from the balloon expandable stent portion.

It will be seen that by this invention there is provided an arrangementby which the balloon expandable stent portion which is substantiallyrigid can extend from a main graft across an aneurised space to the sidebranch artery or vessel and then within the side branch artery thedevice has self expanding stents disposed within or outside the tubulargraft material which provide a degree of flexibility to reduce theincidence of stenosis or fibrosis.

Preferably, there is a portion of the balloon expandable stent portionwhich extends beyond the proximal end of the tubular graft materialportion. This extension portion allows for expansion of the balloonexpandable stent beyond the diameter of the tubular graft material inthat extension portion. This enables the extension portion of theballoon expandable stent to be flared to enable it to be connected intoa fenestration in a main graft so that it is securely received in it.

The tubular graft material can include polytetrafluoroethylene, dacron,polyamide or any other suitable biocompatible graft material.

While DACRON, expanded polytetrafluoroethylene (ePTFE), or othersynthetic biocompatible materials can be used for the tubular graftmaterial for the stent graft, a naturally occurring biomaterial, such ascollagen, is highly desirable, particularly a specially derived collagenmaterial known as an extracellular matrix (ECM), such as smallintestinal submucosa (SIS). Besides SIS, examples of ECM's includepericardium, stomach submucosa, liver basement membrane, urinary bladdersubmucosa, tissue mucosa, and dura mater.

SIS is particularly useful, and can be made in the fashion described inBadylak et al., U.S. Pat. No. 4,902,508; Intestinal Collagen Layerdescribed in U.S. Pat. No. 5,733,337 to Carr and in 17 NatureBiotechnology 1083 (Nov. 1999); Cook et al., WIPO Publication WO98/22158, dated 28 May 1998, which is the published application ofPCT/US97/14855, the teachings of which are incorporated herein byreference. Irrespective of the origin of the material (synthetic versusnaturally occurring), the material can be made thicker by makingmultilaminate constructs, for example SIS constructs as described inU.S. Pat. Nos. 5,968,096; 5,955,110; 5,885,619; and 5,711,969. Inaddition to xenogenic biomaterials, such as SIS, autologous tissue canbe harvested as well, for use in forming the tubular graft material.Additionally Elastin or Elastin-Like Polypetides (ELPs) and the likeoffer potential as a material to fabricate the tubular graft material toform a device with exceptional biocompatibility.

SIS is available from Cook Biotech, West Lafayette, Ind., USA.

The self expanding stent can include Nitinol™, stainless steel or anyother suitable material.

The balloon expandable stent portion can include a shape memory materialsuch as titanium, magnesium, nickel, alloys and the like.

When the tubular graft material is disposed inside the balloonexpandable portion the portion of the self expanding stents extendinginto the balloon expandable portion will assist to hold the tubulargraft material against the balloon expandable stent portion. Stitchingcan be provided to retain the tubular graft material to each of the selfexpanding stents and the balloon expanding stents.

The self expanding stents can be provided either inside or outside thetubular graft material. For instance they can be provided outside alongpart of the length and inside at the distal end so that the outsidesurface of the tubular graft material provides a good seal against thewall of the branch artery or vessel when deployed.

In a further form the invention can be said to reside in a stent grafthaving tubular body with a lumen therethrough, a first portion at oneend of the tubular body that can be flared to retain the stent in afenestration in another stent graft positioned in a main vessel, asecond relatively rigid central portion that can bridge from thefenestration to a branch vessel of the main vessel and a thirdrelatively flexible portion that can extend into a branch vessel toconform thereto.

Preferably the second and third portions include a covering or lining ofbiocompatible graft material.

In a preferred embodiment of the invention the first and second portionscomprise or include a balloon expandable stent. The third portion maycomprise or include self expanding stents.

In a further form the invention comprises a composite stent graftcomprising a biocompatible graft material tube, a balloon expandablestent disposed inside or outside a first part of the graft material tubeand extending from the graft material tube at one end thereof and atleast one self expanding stent associated with a second part of thegraft material tube.

Preferably the at least one self expanding stent associated with thesecond part of the graft material tube comprises a plurality of externalself expanding stents and at least one terminal internal self expandingstent.

In a further form the invention comprises a method of retaining a sidebranch stent graft into a fenestration in a main graft, the side branchstent graft having a tubular body with a lumen therethrough, a firstportion at one end thereof being balloon expandable, a second relativelyrigid central portion that can bridge from the fenestration and a thirdrelatively flexible portion, the method including the steps of;deploying the side branch stent graft through the fenestration such thatat least part of the first portion remains within the main stent graft;and expanding a balloon in the region of the fenestration whereby toflare that part of the first portion which is within the main stentgraft, whereby to assist with retention of the side branch stent graftinto the fenestration in the main graft.

Preferably the step of expanding the balloon includes the step ofexpanding a first balloon in the second portion to retain the positionof the side branch stent graft and expanding a second balloon in theregion of the fenestration whereby to flare that part of the firstportion which is within the main stent graft. Preferably the firstballoon is a non-compliant balloon and the second balloon is a compliantballoon.

U.S. Pat. No. 6,206,931 entitled “Graft Prosthesis Materials” disclosesgraft prosthesis materials and a method for implanting, transplanting,replacing and repairing a part of a patient and particularly themanufacture and use of a purified, collagen based matrix structureremoved from a submucosa tissue source. These features and otherfeatures disclosed in U.S. Pat. No. 6,206,931 could be used with thepresent invention and the disclosure of U.S. Pat. No. 6,206,931 isherewith incorporated in its entirety into this specification.

U.S. Pat. No. 5,387,235 entitled “Expandable Transluminal GraftProsthesis For Repair Of Aneurysm” discloses apparatus and methods ofretaining grafts onto deployment devices. These features and otherfeatures disclosed in U.S. Pat. No. 5,387,235 could be used with thepresent invention and the disclosure of U.S. Pat. No. 5,387,235 isherewith incorporated in its entirety into this specification.

U.S. Pat. No. 5,720,776 entitled “Barb and Expandable Transluminal GraftProsthesis For Repair of Aneurysm” discloses improved barbs with variousforms of mechanical attachment to a stent. These features and otherfeatures disclosed in U.S. Pat. No. 5,720,776 could be used with thepresent invention and the disclosure of U.S. Pat. No. 5,720,776 isherewith incorporated in its entirety into this specification.

U.S. Pat. No. 6,206,931 entitled “Graft Prosthesis Materials” disclosesgraft prosthesis materials and a method for implanting, transplantingreplacing and repairing a part of a patient and particularly themanufacture and use of a purified, collagen based matrix structureremoved from a submucosa tissue source. These features and otherfeatures disclosed in U.S. Pat. No. 6,206,931 could be used with thepresent invention and the disclosure of U.S. Pat. No. 6,206,931 isherewith incorporated in its entirety into this specification.

PCT Patent Publication No. WO 98/53761 entitled “A Prosthesis And AMethod And Means Of Deploying A Prosthesis” discloses an introducer fora prosthesis which retains the prosthesis so that each end can be movedindependently. These features and other features disclosed in PCT PatentPublication No. WO 98/53761 could be used with the present invention andthe disclosure of PCT Patent Publication No. WO 98/53761 is herewithincorporated in its entirety into this specification.

PCT Patent Publication No. WO 99/29262 entitled “Endoluminal AorticStents” discloses a fenestrated prosthesis for placement where there areintersecting arteries. This feature and other features disclosed in PCTPatent Publication No. WO 99/29262 could be used with the presentinvention and the disclosure of PCT Patent Publication No. WO 99/29262is herewith incorporated in its entirety into this specification.

PCT Patent Publication No. WO 03/034948 entitled “Prosthesis For CurvedLumens” discloses prostheses with arrangements for bending theprosthesis for placement into curved lumens. This feature and otherfeatures disclosed in PCT Patent Publication No. WO 03/034948 could beused with the present invention and the disclosure of PCT PatentPublication No. WO 03/034948 is herewith incorporated in its entiretyinto this specification.

U.S. Provisional Patent Application Ser. No. 60/392,667, filed Jun. 28,2002, and U.S. patent application Ser. No. 10/609,846, filed Jun. 30,2003, entitled “Thoracic Deployment Device” disclose introducer devicesadapted for deployment of stent grafts particularly in the thoracicarch. This feature and other features disclosed in U.S. ProvisionalPatent Application Ser. No. 60/392,667 and U.S. patent application Ser.No. 10/609,846, filed Jun. 30, 2003 could be used with the presentinvention and the disclosure of U.S. Provisional Patent Application Ser.No. 60/392,667 and U.S. patent application Ser. No. 10/609,846, filedJun. 30, 2003 are herewith incorporated in their entirety into thisspecification.

U.S. Provisional Patent Application Ser. No. 60/392,599, filed Jun. 28,2002, and U.S. patent application Ser. No. 10/609,835, filed Jun. 30,2003, entitled “Thoracic Aortic Aneurysm Stent Graft” disclose stentgrafts that are useful in treating aortic aneurysms particularly in thethoracic arch. This feature and other features disclosed in U.S.Provisional Patent Application Ser. No. 60/392,599 and U.S. patentapplication Ser. No. 10/609,835, filed Jun. 30, 2003 could be used withthe present invention, and the disclosure are herewith incorporated intheir entirety into this specification.

U.S. Provisional Patent Application Ser. No. 60/391,737, filed Jun. 26,2002, U.S. patent application Ser. No. 10/602,930, filed Jun. 24, 2003,and PCT Patent Publication Number WO 2004/002365 entitled “Stent-GraftFastening” disclose arrangements for fastening stents onto graftsparticularly for exposed stents. This feature and other featuresdisclosed in U.S. Provisional Patent Application No. 60/391,737, U.S.patent application Ser. No. 10/602,930, and PCT Patent PublicationNumber WO 2004/002365 could be used with the present invention and thedisclosure of U.S. Provisional Patent Application Ser. No. 60/391,73,U.S. patent application Ser. No. 10/602,930, and PCT Patent PublicationNumber WO 2004/002365 are herewith incorporated in its entirety intothis specification.

U.S. Provisional Patent Application Ser. No. 60/405,367, filed Aug. 23,2002, U.S. patent application Ser. No. 10/647,642, filed Aug. 25, 2003,and PCT Patent Publication No. WO 2004/017868 entitled “Asymmetric StentGraft Attachment” disclose retention arrangements for retaining onto andreleasing prostheses from introducer devices. This feature and otherfeatures disclosed in U.S. Provisional Patent Application Ser. No.60/405,367, filed Aug. 23, 2002, U.S. patent application Ser. No.10/647,642, filed Aug. 25, 2003, and PCT Patent Publication No. WO2004/017868 could be used with the present invention and the disclosureof U.S. Provisional Patent Application Ser. No. 60/405,367, filed Aug.23, 2002, U.S. patent application Ser. No. 10/647,642, filed Aug. 25,2003, and PCT Patent Publication No. WO 2004/017868 are herewithincorporated in its entirety into this specification.

U.S. patent application Ser. No. 10/322,862, filed Dec. 18, 2002 andpublished as Publication No. US2003-0120332, and PCT Patent PublicationNo. WO03/053287 entitled “Stent Graft With Improved Adhesion” disclosearrangements on stent grafts for enhancing the adhesion of such stentgrafts into walls of vessels in which they are deployed. This featureand other features disclosed in U.S. patent application Ser. No.10/322,862, filed Dec. 18, 2002 and published as Publication No.US2003-0120332, and PCT Patent Publication No. WO03/053287 could be usedwith the present invention and the disclosure of U.S. patent applicationSer. No. 10/322,862, filed Dec. 18, 2002 and published as PublicationNo. US2003-0120332, and PCT Patent Publication No. WO03/053287 areherewith incorporated in its entirety into this specification.

U.S. Provisional Patent Application Ser. No. 60/405,769, filed Aug. 23,2002, U.S. patent application Ser. No. 10/645,095, filed Aug. 23, 2003,and PCT Patent Publication Number WO 2004/017867 entitled “CompositeProstheses” discloses prostheses or stent grafts suitable forendoluminal deployment. These prostheses and other features disclosed inU.S. Provisional Patent Application Ser. No. 60/405,769, filed Aug. 23,2002, U.S. Patent Application Ser. No. 10/645,095, filed Aug. 23, 2003,and PCT Patent Publication Number WO 2004/017867, could be used with thepresent invention and the disclosure of U.S. Provisional PatentApplication Ser. No. 60/405,769, filed Aug. 23, 2002, U.S. patentapplication Ser. No. 10/645,095, filed Aug. 23, 2003, and PCT PatentPublication Number WO 2004/017867 are herewith incorporated in itsentirety into this specification.

This then generally describes the invention but to assist withunderstanding reference will now be made to the accompanying drawingswhich show a preferred embodiment of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a longitudinal cross-sectional view of a composite stentgraft according to one embodiment of this invention;

FIG. 2 shows the composite stent graft of FIG. 1 compressed and receivedin a deployment device;

FIG. 3 shows a schematic view of deployment of side branch stent graftsfrom a main graft;

FIGS. 4 to 7 show various stages of deployment of the composite stentgraft according to this invention into a side branch artery from a maingraft; and

FIG. 8 shows an alternative method of expansion of part of the compositestent graft.

DETAILED DESCRIPTION OF THE DRAWINGS AND THE PRESENTLY PREFERREDEMBODIMENTS

Now looking more closely at FIGS. 1 and 2, it will be seen that thecomposite stent graft includes a tubular graft material 1 and within thetubular graft material there is an balloon expandable stent 3 (shown inan expanded configuration in FIG. 1 and in a radially compressedcondition in FIG. 2) and a number of self expanding stents 5. Theballoon expandable stent 3 has a particular configuration of strutsshown but the invention is not limited to any one configuration ofstruts. The balloon expandable stent 3 has an extension portion 7 whichextends beyond the proximal end 9 of the tubular graft material 1. Thetubular graft material 1 is stitched at 11 to the balloon expandablestent. Further stitching can also be provided. The self expanding stents5 are positioned on the outside of the tubular graft material in theregion 13 and the final self expanding stent 15 is positioned on theinside of the tubular graft material 1 at the distal end 17 of thetubular graft material 1.

The extension portion 7 comprises the first portion discussed above, theremainder of the balloon expandable stent 3 comprises the second portionand the self expanding stents 5 and 5 comprise the relatively flexibleportion of the composite stent graft.

The balloon expandable stent 3 may be a radially expandable surgicalstent formed from a shape memory material such as a nickel-titaniumalloy. The stent can include a series of wave-like struts spaced apartby gaps. Each gap can be spanned by tie bars at a maximum width portionof the gap and/or by angled links or straight links at a minimum widthportion of a gap. Hence, axial expansion or contraction of the stent isavoided when the stent is radially expanded.

The self expanding stents 5 and 15 can be zig zag Gianturco style Zstents having a plurality of struts with bends between the struts andformed into a substantially cylindrical form.

FIG. 2 shows the stent graft of FIG. 1 compressed and received within adeployment device.

The deployment device includes a guide wire catheter 20 with a nose cone22 at one end and sheath 24 covering the stent graft and holding theself expanding stents 5 and 15 in a radially compressed or collapsedcondition.

On the guide wire catheter 20 is an inflatable balloon 26 which can beinflated with suitable material to expand the balloon expandable stentportion of the stent graft as required. It will be realised that in someembodiments the balloon can be provided on a separate balloon catheterdeployed over the guide wire 21 after the deployment of the device aswill be discussed later.

FIG. 3 shows a schematic view of the deployment of a main graft into aaneurysed aorta and the deployment of side branch grafts from the maingraft into renal arteries. The aorta 30 has an aneurysm 31 and a maingraft 33 has been deployed into the aneurised space. The main graft 33has super-renal uncovered stent 35 which is received in a non-aneurysedregion of the aorta and provides a top support for the main graft 33.The main aneurised region 31, however, extends up past the renalarteries 37 and 39 and as such is necessary to provide side branchgrafts to these arteries.

For this purpose there are fenestrations 41 provided into the main graftand it is through these fenestrations that the side branch or compositestent grafts 43 are deployed as will be discussed in more detail inrespect to FIGS. 4-7.

It will be noted, however, that the side branch stent grafts 43extending from the main graft to the renal arteries 37 and 39 cross aregion of aneurised region 31. If there was movement of the main graft33 with respect to the aneurysm and if there was a non-rigid portion ofstent graft in this space the lumen of the side branch graft could beclosed off by kinking. The expanded balloon expandable portion of thestent graft in this region will act to prevent this occurring.

FIGS. 4-7 show the various stages in deployment of a branched stentgraft from a main graft into a side branch artery for instance.

As can be seen in FIG. 4 a main graft 33 has been deployed into an aortaand extends through an aneurised space 31. The main graft has afenestration 41 with radiopaque markers 45 around its periphery whichassist a surgeon in locating the fenestration with respect to the sidebranch artery 37 after the main graft 33 has been deployed. The sidebranch artery 37 has had a guide wire 47 deployed into it and adeployment catheter with the stent graft according to this inventionmounted onto it of the type shown in FIG. 2 has been deployed over theguide wire 47. The sheath 24 has been withdrawn. This allows the selfexpanding stents 5 and 15 to expand within the side branch artery 37 sothat the tubular graft material 1 is engaged against the wall of theartery.

The balloon 26, however, has not been expanded and therefore the balloonexpandable stent 3 of the stent graft is not expanded.

As can be seen in FIG. 5, the balloon 26 has been expanded by knownmeans and the balloon expandable stent 3 has expanded to engage againstthe walls of the side branch artery 37.

The balloon 26 is then deflated and the deployment device on guide wire20 is then removed leaving the guide wire 20 in place.

As depicted in FIG. 6, another balloon catheter 50 is then deployed overthe guide wire 20 and the balloon 52 on the balloon catheter 50 ispositioned so that it is partially within the proximal end of the stentgraft and partially outside the stent graft in the region of thefenestration 41 and then it is expanded. Expansion causes the extensionportion 7 to be flared so that the proximal end of the stent graft 7 isfirmly received within the fenestration 41 of the main graft 33.

As shown in FIG. 7 the flaring can be extended to the extent that theextension portion 7 is completely flared against the inside wall of thestent graft.

A blood flow path is therefore provided from the main graft into thebranch artery 37 which includes a rigid portion across the aneurisedspace 31 and a more flexible portion within the branch artery 37. Thiswill assist with prevention of stenosis at the junction between thestent graft and the side branch artery.

FIG. 8 shows an alternative method to that shown in FIG. 6 for theexpansion and flaring of the extension portion 7 of the composite stentgraft so that the proximal end of the stent graft 7 is firmly receivedwithin the fenestration 41 of the main graft 33.

For this method a dual balloon catheter 60 is used. The dual ballooncatheter 60 has a first balloon 62 near its proximal end and a secondballoon 64 just distal of the first balloon 62. Both the balloons areseparately inflatable by the use of multiple lumens in the catheter. Thedual balloon catheter 60 is deployed over the guide wire 20 so that theballoon 62 is fully received within the balloon expanded portion 3 ofthe composite stent. This balloon 62 can be used to expand the balloonexpanded portion 3 as discussed in relation to FIG. 5 or can be usedafter the stage discussed in relation to FIG. 5 has been performed. Theballoon 62 is expanded or left expanded and then the balloon 64 isexpanded to cause the flaring of the balloon expanded portion 3 of thecomposite stent so that the proximal end of the stent graft 7 is firmlyreceived within the fenestration 41 of the main graft 33.

Preferably the balloon 62 used to hold the composite stent in placewhile the flaring takes place is a non-compliant balloon so that excessforce is not placed on the composite stent graft and the balloon 64 isof a compliant nature so that it can expand enough to flare the end 7against the inner wall of the main graft 33.

It will be realised that the relative lengths of the balloon expandableportion and the self expanding portion can be varied depending upon thesize of the aneurysm to be treated, the desired extension of the morerigid section into the side branch artery and the morphology of the sidebranch vessel.

Throughout this specification various indications have been given as tothe scope of this invention but the invention is not limited to any oneof these but may reside in two or more of these combined together. Theexamples are given for illustration only and not for limitation.

Throughout this specification and the claims that follow unless thecontext requires otherwise, the words ‘comprise’ and ‘include’ andvariations such as ‘comprising’ and ‘including’ will be understood toimply the inclusion of a stated integer or group of integers but not theexclusion of any other integer or group of integers.

1. A method of placing a side branch stent graft into a fenestration ofa main stent graft having a first end, a second end, a main lumen, aside wall, and a fenestration in the side wall, the side branch stentgraft comprising a tubular body of biocompatible graft material having afirst end and a second end, a lumen therethrough, an inside, an outside,a balloon radially expandable stent having a tubular portion inside thefirst end of the tubular body and having a selected diameter and aflareable extension portion extending longitudinally beyond the firstend of the tubular body such that the extension portion of the balloonexpandable stent is expandable radially beyond the selected diameter ofthe tubular body, a plurality of self radially expanding stents spacedapart on the tubular body and positioned on the outside of the tubularbody towards the second end of the tubular body and a terminal selfradially expanding stent on the inside of the tubular body at the secondend of the tubular body, the method comprising inserting the side branchgraft through the fenestration of the main stent graft such that theextension portion of the side branch graft is disposed within the mainlumen and the tubular body is disposed in a side branch vessel, flaringthe extension portion of the balloon expandable stent beyond theselected diameter of the tubular body, expanding the balloon expandablestent within the lumen of the tubular body, and expanding the selfexpanding stents.
 2. The method of claim 1, wherein the balloonexpandable stent extends from about the middle of the side branch graftto beyond the first end of the side branch graft.
 3. The method of claim1, wherein the extension portion is flared with a first balloon, and thetubular body is expanded with a second balloon.
 4. The method of claim3, wherein the second balloon is expanded to retain the position of theside branch stent graft in the side branch vessel.
 5. The method ofclaim 4, wherein the second balloon is expanded to retain the positionof the side branch stent graft in the side branch vessel prior toflaring the extension portion.
 6. The method of claim 4, wherein thesecond balloon is a non-compliant balloon and the first balloon is acompliant balloon.
 7. The method of claim 1, wherein the tubular bodycomprises a first region and a second region wherein the first region ismore rigid than the second region.
 8. The method of claim 7, wherein thefirst region comprises the balloon expandable stent and the secondregion comprises the self-expanding stents.
 9. The method of claim 8,wherein the first region is placed at least partially within thefenestration, and the second region is placed within the side branchvessel.
 10. A method of placing a side branch graft into a fenestrationof a previously placed stent graft, the previously placed stent grafthaving a first end, a second end, a main lumen, a side wall, and afenestration in the side wall, the side branch stent graft having afirst end, a second end, a first region and a second region, a balloonexpandable stent disposed partially inside the side branch stent graftin the first region and an extension portion extending beyond the firstend of the side branch stent graft, and a plurality of self-expandingstents disposed at the second region, the method comprising: insertingthe side branch stent graft through the main lumen and at leastpartially through the fenestration and into a side branch vessel,expanding a balloon within the balloon expandable stent in the firstregion to expand the balloon expandable stent and retain the position ofthe tubular body in the side branch vessel, and flaring the extensionportion by expanding a balloon within the extension portion.
 11. Themethod of claim 10, wherein the balloon comprises a first compliantregion and a second non-compliant region.
 12. The method of claim 10,wherein the steps of expanding the first region and flaring theextension portion are performed with a single balloon.
 13. The method ofclaim 10, wherein the steps of expanding the first region and flaringthe extension portion are performed with first and second balloons. 14.The method of claim 13, wherein the first balloon is non-compliant andthe second balloon is compliant.
 15. The method of claim 10, wherein thestep of flaring the extension portion comprises engaging the extensionportion against an inside wall of the previously placed stent graft. 16.The method of claim 10, wherein the step of expanding a balloon withinthe balloon expandable stent in the first region is performed prior toflaring the extension portion.
 17. A method of repairing a damaged mainvessel at a junction of the main vessel and branch vessel, the methodcomprising: introducing a main stent graft having a first end, a secondend, a main lumen, a side wall, and at least one fenestration in theside wall into the main vessel, aligning the at least one fenestrationwith the branch vessel, deploying the main stent graft, introducing aside branch stent graft into the main lumen and at least partiallythrough the at least one fenestration and into the side branch vessel,the side branch stent graft comprising a tubular body of biocompatiblegraft material having a first end and a second end, a lumentherethrough, an inside, an outside, a balloon radially expandable stenthaving a tubular portion inside the first end of the tubular body andhaving a selected diameter and a flareable extension portion extendinglongitudinally beyond the first end of the tubular body such that theextension portion of the balloon expandable stent is expandable radiallybeyond the selected diameter of the tubular body, a plurality of selfradially expanding stents spaced apart on the tubular body andpositioned on the outside of the tubular body towards the second end ofthe tubular body and a terminal self radially expanding stent on theinside of the tubular body at the second end of the tubular body,expanding the tubular portion of the side branch graft with a balloon toretain it in the side branch vessel, and flaring the extension portionwith a balloon to position the extension portion within the main lumenand against an inside wall of the main stent graft.
 18. The method ofclaim 17, wherein the step of expanding the tubular portion occurs priorto the step flaring the extension portion.
 19. The method of claim 17,wherein the steps of expanding the tubular portion and flaring theextension portion are performed with the same balloon.
 20. The method ofclaim 17, wherein the steps of expanding the tubular portion and flaringthe extension portion are performed with separate balloons.